MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	32375
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city - (b)(6).
Event or Problem Description
It was reported that the catheter broke.A flexima nephrostomy drainage catheter had been placed for drainage of the kidney.It was noted there was difficulty pulling the suture and the catheter broke.A new flexima catheter was used.There were no patient complications reported.
Event or Problem Description
It was reported that the catheter broke.A flexima nephrostomy drainage catheter had been placed for drainage of the kidney.It was noted there was difficulty pulling the suture and the catheter broke.A new flexima catheter was used.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter city - (b)(6).Device analysis by manufacturer: unit returned with its original pouch.The catheter was returned for analysis; moreover, the flexible cannula was loaded in the catheter, and no damages were observed.The flexible cannula was inserted and retracted from the catheter without issues.

• Brand Name: FLEXIMA
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15538783
• Report Number: 2124215-2022-38970
• Device Sequence Number: 12116026
• Product Code: GBO
• UDI-Device Identifier: 08714729323303
• UDI-Public: 08714729323303
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2025
• Device Model Number: 32375
• Device Catalogue Number: 32375
• Device Lot Number: 0029070485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown